[Federal Register Volume 67, Number 46 (Friday, March 8, 2002)]
[Notices]
[Pages 10715-10717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5736]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42212F; FRL-6827-9]


Endocrine Disruptor Method Validation Subcommittee Under the 
National Advisory Council for Environmental Policy and Technology; 
Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a meeting of the Endocrine Disruptor Methods 
Validation Subcommittee (EDMVS), a subcommittee under the National 
Advisory Council for Environmental Policy and Technology (NACEPT), a 
Federal Advisory Committee, on March 25th - 27th, 2002. The EDMVS will 
provide technical advice on screening and testing methods for the 
Endocrine Disruptor Screening Program (EDSP). The upcoming meeting, as 
with all EDMVS meetings, is open to the public. Seating is on a first-
come basis. Individuals requiring special accommodations at this 
meeting, including wheelchair access, should contact Jane Smith at the 
address listed under FOR FURTHER INFORMATION CONTACT at least 5 
business days prior to the meeting, so appropriate arrangements can be 
made.

DATES: The meeting will be held on March 25, 2002, from 1 p.m. to 5:45 
p.m., March 26 from, 9 a.m. to 4:15 p.m., and March 27 from, 9 a.m. to 
12:15 p.m.
    Requests to participate in the meeting must be received on or 
before March 20, 2002.

[[Page 10716]]


ADDRESSES: The meeting will be held at RESOLVE, 1255 23rd St., NW, 
Suite 275, Washington, DC. The telephone number for RESOLVE is (202) 
944-2300.
    Requests to participate in the meeting may be submitted by 
electronic mail, telephone, or in person. Please follow the detailed 
instructions for each method as provided in Unit III. under 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
request must identify docket control number OPPT-42212F in the subject 
line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Designated Federal 
Official, Office of Science Coordination and Policy, Mail Code 7201M, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (202) 564-8476; fax number: 
(202) 564-8483; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest if you produce, manufacture, use, consume, work 
with, or import pesticides chemicals, substances that may have an 
effect cumulative to an effect of a pesticide, or substances found in 
sources of drinking water. To determine whether you or your business 
may have an interest in this notice you should carefully examine 
section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (Public Law 104-
170), 21 U.S.C. 346A(p) and amendments to the Safe Drinking Water Act 
(Public Law 104-182), 42 U.S.C. 300j-17. Since other entities may also 
be interested, the Agency has not attempted to describe all the 
specific entities that may be affected by this action. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

II. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. A list of EDMVS members and information from 
previous meetings is available electronically, from the EPA Internet 
Home Page at http://www.epa.gov/scipoly/oscpendo. To access this 
document, on the EPA Home Page search for ``Endocrine,'' which will 
take you to the EDSP web site. You can also go directly to the Federal 
Register listing at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an administrative record 
for this meeting under docket control number OPPT-42212F. The 
administrative record consists of the documents specifically referenced 
in this notice, any public comments received during an applicable 
comment period, and other information related to Endocrine Disruptor 
Method Validation, including any information claimed as Confidential 
Business Information (CBI). The public version of the administrative 
record is available for inspection in the TSCA Nonconfidential 
Information Center, North East Mall, Rm B-607, Waterside Mall, 401 M 
St., SW., Washington, DC. The Center is open form noon to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
of the Center is (202) 260-7099.

III. How Can I Request to Participate in this Meeting?

    You may submit a request to participate in the meeting by 
electronic mail, telephone, by fax, or in person. We would normally 
accept requests by mail, but in this time of delays in delivery of 
government mail due to health and security concerns, we cannot assure 
your request would arrive in a timely manner. Do not submit any 
information in your request that is considered CBI. Your request must 
be received by EPA on or before March 20, 2002. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPPT-42212F, in the subject line on the first page of your 
request.
    1. Electronically. You may submit your request electronically by e-
mail to [email protected]. Do not submit any information 
electronically that you consider to be CBI. Use WordPerfect 6.1/8.0 or 
ASCII file format and avoid the use of special characters and any form 
of encryption. Be sure to identify by docket control number OPPT-
42212F. You may also file a request online at many Federal Depository 
Libraries.
    2. In person or by courier. You may deliver a request to: OPPT 
Docket Control Office, North East Mall, Rm B-607, Waterside Mall, 401M 
St., SW., Washington, DC. The docket office is open from noon to 4 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number of the Office is (202) 260-7099.
    3. Fax. You may fax your request to: Jane Smith, Designated Federal 
Official, list under FOR FURTHER INFORMATION CONTACT.

IV. Background

    In 1996, through enactment of the Food Quality Protection Act, 
which amended the FFDCA, Congress directed EPA to develop a screening 
program, using appropriate validated test systems and other 
scientifically relevant information, to determine whether certain 
substances may have hormonal effects in humans. In 1996, EPA chartered 
a scientific advisory committee, the Endocrine Disruptor Screening and 
Testing Advisory Committee (EDSTAC), under the authority of the Federal 
Advisory Committee Act (FACA ) to advise it on establishing a program 
to carry out Congress' directive. EDSTAC recommended a multi-step 
approach including a series of screens (Tier 1 Screens) and tests (Tier 
2 tests) for determining whether a chemical substance may have an 
effect similar to that produced by naturally occurring hormones. EPA 
adopted almost all of EDSTAC's recommendations in the Program that it 
developed, the Endocrine Disruptor Screening Program (EDSP), to carry 
out Congress' directive.
    EDSTAC also recognized that there currently are no validated test 
systems for determining whether a chemical may have an effect in humans 
that is similar to an effect produced by naturally occurring hormones. 
Consequently, EPA is in the process of developing and validating the 
screens and tests that EDSTAC recommended for inclusion in the EDSP. In 
carrying out this validation exercise, EPA is working closely with, and 
adhering to the principles of the Interagency Coordinating Committee 
for the Validation of Alternate Methods (ICCVAM). EPA also is working 
closely with the Organization for Economic Cooperation and 
Development's Endocine Testing and Assessment Task Force to validate 
and harmonize endocrine screening tests of international interest.
    Finally, to ensure that EPA has the best and most up-to-date advice 
available regarding the validation of the screens and tests in the 
EDSP, EPA recently chartered the EDMVS of the NACEPT. The EDMVS 
provides independent advice and counsel to the Agency through NACEPT, 
on scientific and technical issues related to validation of the EDSP 
Tier I screens and Tier II tests, including advice on methods for 
reducing animal use, refining procedures involving animals to make them 
less stressful, and replacing animals where scientifically appropriate.
    The EDMVS has met twice since its establishment in September 2001. 
The

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objectives of the October 2001 meeting (docket control number 42212D) 
were for EPA to provide:
     An overview of EPA's Endocrine Disruptor Program.
     Background information on test protocol validation and 
approaches.
     For the EDMVS to develop a clear understanding of their 
scope, purpose and operating procedures.
     For the EDMVS and the EDSP to determine the next steps.
    The objectives of the December 2001 meeting (docket control number 
42212E) were for the EDMVS to provide input and advice on:
     The EDMVS's mission statement and work plan.
     The in utero through lactation assay detailed review 
paper.
     The pubertal assay study design for the multi-dose and 
chemical array protocols.
     The mammalian one-generation study design.
    A list of the EDMVS members and meeting materials are available on 
our web site, (http://www.epa.gov/scipoly/oscpendo/edmvs.htm), and in 
the public docket.

V. Meeting Objectives for the March 2002 Meeting

    The objectives of the March meeting are for the EDMVS to provide 
input and advice on:
     EDSP's implementation process and practical aspects of 
validation.
     The in utero through lactation assay protocol.
     The fish reproduction assay detailed review paper.
     Special studies on fathead minnow assays, vitellogenin 
assay, and avian dosing protocol.
     The aromatase detailed review paper.
     A proposed standard suite of chemicals for testing in the 
Tier 1 screening assay.
    Time for public comment has been reserved on March 25th and 26th 
just prior to meeting adjournment for the day.

List of Subjects

    Environmental protection, Endocrine disruptor screening program, 
Endocrine disruptors.

    Dated: March 4, 2002.
  Andy Privee,
Acting Director, Office of Science Coordination and Policy, Office of 
Prevention, Pesticides and Toxic Substances.
[FR Doc. 02-5736 Filed 3-6-02; 2:21 pm]
BILLING CODE 6560-50-S